BridgeMD
Compares treatment options for Acute Graft Versus Host Disease
Official title Leflunomide in Combination With Steroids for the Treatment of Acute Graft-versus-Host Disease After Donor Stem Cell Transplant for Hematologic Malignancies
ClinicalTrials.gov ID: NCT05443425
What this study is testing
What is Cholestyramine?
Cholestyramine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute graft versus host disease.
Also referred to as Cholybar, Colestyramine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase I trial tests the safety and side effects of leflunomide in combination with steroids in treating patients with acute graft versus host disease who have undergone done stem cell transplant for blood cancers (hematologic malignancies). Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
- Age \>= 18 years old
You likely can't join if
- Recipient of more than one allogeneic HCT
- Received more than 3 days of systemic corticosteroid for treatment of aGvHD
- Presence of GVHD overlap syndrome
- Prior treatment with leflunomide
- Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period
- Use of other drugs for treatment of acute GvHD
See the full eligibility criteria
Who can join
- Documented informed consent of the participant and/or legally authorized representative
- Assent, when appropriate, will be obtained per institutional guidelines
- Agreement to allow the use of archival tissue from diagnostic tumor biopsies
- If unavailable, exceptions may be granted with study principal investigator (PI) approval
- Age \>= 18 years old
- Karnofsky performance status \>= 70
- Clinically suspected grade II-IV aGvHD based on Mount Sinai Acute GVHD International Consortium (MAGIC) Consensus criteria occurring after allogeneic hematopoietic cell transplantation (HCT) and GvHD prophylaxis...
- Note: HCT from any donor (related or unrelated with any degree of human leukocyte antigen [HLA] matching) and any graft source (bone marrow, peripheral blood stem cells, or cord blood) for hematologic malignancy or...
- Biopsy of acute GvHD target organ is recommended but not required. Enrollment should not be delayed for biopsy or pathology results. Patients who do not enroll within 72 hours from start of steroids are not permitted to...
- Evidence of myeloid engraftment (e.g., absolute neutrophil count [ANC] \>= 0.5 x 10\^9/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed
- No prior systemic treatment for treatment of acute GvHD except for a maximum of 72 hours of prednisone =\< 2 mg/kg/day (or intravenous [IV] methylprednisone equivalent). Topical skin steroid treatment and non-absorbable...
- Patients should be able to swallow and retain oral medication
- Total bilirubin =\< 2 X ULN (unless has Gilbert's disease or aGvHD within 3 days of enrollment) (performed within 14 days prior to day 1 of protocol therapy)
- Aspartate aminotransferase (AST) =\< 3 x upper limit of normal (ULN) (performed within 14 days prior to day 1 of protocol therapy)
- Alanine aminotransferase (ALT) =\< 3 x ULN (performed within 14 days prior to day 1 of protocol therapy)
- Creatinine clearance of \>= 50 mL/min per 24-hour urine test or the Cockcroft-Gault formula (performed within 14 days prior to day 1 of protocol therapy)
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
What rules you out
- Recipient of more than one allogeneic HCT
- Received more than 3 days of systemic corticosteroid for treatment of aGvHD
- Presence of GVHD overlap syndrome
- Prior treatment with leflunomide
- Current or planned use of other investigational agents, or concurrent biological, chemotherapy, or radiation therapy during the study treatment period
- Use of other drugs for treatment of acute GvHD
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent (leflunomide or cholestyramine)
- Clinically significant uncontrolled illness
- Patients on dialysis
- Patient requiring ventilator support
- Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributed to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable...
- Known history of immunodeficiency virus (HIV) infection
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment, HBV deoxyribonucleic acid (DNA) and HCV ribonucleic acid (RNA) must be undetectable upon testing. Prior test results obtained...
- people with evidence of relapsed primary disease, or people who have been treated for relapse after the allogeneic (allo)-HCT was performed
- Severe organ dysfunction unrelated to underlying GvHD, including:
- Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GvHD and ongoing organ dysfunction)
- Clinically significant uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV congestive heart failure, circulatory...
- Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen
- Non-hematologic malignancy within the past 3 years aside from the following exceptions:
- Adequately treated basal cell or squamous cell skin cancer
- Carcinoma in situ of the cervix
- Prostate cancer \< Gleason Grade 6 with a stable prostate specific antigen (PSA)
- Successfully treated in situ carcinoma of the breast
- Females only: Pregnant or breastfeeding
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. e.g., infection/inflammation...
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.